Easy@Home OXY Single Drug Screen Test (25 tests kit)

GUDID 10855944007724

Easy@Home Single Drug Screen Test; 25 tests kit; OXY

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10855944007724
NIH Device Record Keyc50ec09f-5a52-4059-b10e-271f8589997b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home OXY Single Drug Screen Test (25 tests kit)
Version Model NumberEDOX-114-25
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100855944007727 [Primary]
GS110855944007724 [Package]
Contains: 00855944007727
Package: Carton [35 Units]
In Commercial Distribution
GS190855944007720 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-12
Device Publish Date2019-08-02

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